Lead operational execution of U.S. clinical studies ensuring GCP and regulatory compliance. Coordinate with CRAs, vendors, and internal teams; manage study documentation, TMF, dashboards, site performance, budgets, and vendor invoicing. Support audits/inspection readiness, regulatory requests, and mentor junior staff while driving process improvements.
Work Flexibility: Remote
Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
The Senior Internal Clinical Research Associate is a supporting role for the Clinical Research team, mainly focused on trial conduct and site management activities in the U.S. following good clinical practice and all applicable regulations. This position will work collaboratively with the external Contract Research Organization, external vendors, field Clinical Research Associates, additional study team members, customers, and other internal partners enabling patient access to advanced care of their venous thromboembolism.
What You Will Do
- Lead operational execution of assigned clinical studies while ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
- Serve as a key liaison between internal study teams, field Clinical Research Associates (CRAs), clinical sites, vendors, and external partners to facilitate successful study execution.
- Support the development, review, and maintenance of study documentation, including protocols, informed consent forms, monitoring plans, case report forms, and study-related materials.
- Oversee Trial Master File (TMF) activities to ensure accuracy, completeness, and inspection readiness.
- Develop and maintain study dashboards, trackers, metrics, and reports to support study oversight and decision-making.
- Monitor site performance metrics and collaborate with study teams to proactively identify and resolve operational challenges.
- Support study budget tracking, site payments, vendor invoicing, and financial reconciliation activities.
- Partner cross-functionally with Clinical Program Management, Data Management, Regulatory Affairs, Quality, and Medical Affairs teams to support study objectives.
- Contribute to audit and inspection readiness activities and support responses to regulatory requests.
- Mentor and provide guidance to junior team members while supporting process improvement initiatives that drive operational excellence.
What You Will Need
- Bachelor's degree in Life Sciences, Health Sciences, Nursing, or a related scientific discipline.
- Minimum of 2+ years of clinical research experience, preferably within a medical device, biotechnology, pharmaceutical, CRO, or sponsor environment.
- Working knowledge of Good Clinical Practice (GCP), FDA regulations, and clinical research processes.
- Experience supporting clinical study operations, study documentation, and trial execution activities.
- Strong organizational, communication, and project management skills.
- Demonstrated ability to manage multiple priorities in a fast-paced environment.
Preferred Qualifications
- Experience supporting U.S. and/or global medical device clinical studies.
- Experience with clinical systems including CTMS, EDC, eTMF, and other clinical trial platforms.
- Experience with study metrics, dashboards, site management, and operational reporting.
- Experience supporting study budgets, site payments, contracts, vendor management, or financial tracking activities.
- Experience supporting audits, inspections, regulatory submissions, or inspection-readiness activities.
- Clinical research certification (SOCRA, ACRP, CCRP, CCRC, or equivalent).
- Experience mentoring, training, or guiding junior team members.
United States of America Pay Ranges:
- USN: $83,300 - $138,800 USD Annual
- US5: $87,500 - $145,700 USD Annual
- US10: $91,600 - $152,700 USD Annual
- US15: $95,800 - $159,600 USD Annual
- US20: $100,000 - $166,600 USD Annual
- US30: $108,300 - $180,400 USD Annual
Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
Stryker Fremont, California, USA Office
47900 Bayside Pkwy, Fremont, CA, United States, 94538
Stryker San Jose, California, USA Office
5900 Optical Ct, San Jose, CA, United States, 95138
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